Articles from Inspection Monitor (January 1, 2006)

Title	Author	Type	Words
483/EIR update.			715
Avid Bioservices advised to follow GMPs for clinical trial drugs, but cleared to produce APIs for Hylenex.			834
Cell cultures, elastomers, GMP failures are common 483 items with disposables.	Pickett, Joseph		546
Incomplete quality audits, non-conforming product procedures and Part 11 noted for Guidant.			579
Inspection log.			298
Lab cited in 1-item 483 for failing to establish specs, standards, test procedures.			346
Lack of Part 11 compliance cited in 7-item 483 for Takeda Chemical.			851
Schering-Plough faulted in 6-item 483 for irregular water system maintenance.			892
Two inspections for blood bank net clean report, 1-item 483.			362